Clinical trial design in hepatocellular carcinoma.

Best Pract Res Clin Gastroenterol

Institute for Cancer Studies, University of Birmingham, Vincent Drive, Edgbaston, Birmingham B15 2TT, UK.

Published: February 2005

Researchers interested in developing treatments for hepatocellular carcinoma (HCC) face three sets of problems; one set common to all clinical trialists at the beginning of the 21st century, one set related to phase I/II studies ('early drug development') and one set related to the design of phase III (randomised, controlled trials). This review is concerned with the challenges faced in designing high quality clinical trials in patients with HCC. Specific published trials are not discussed other than by way of illustration of the problems faced.

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http://dx.doi.org/10.1016/j.bpg.2004.11.004DOI Listing

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